Principal Quality Assurance Compliance Specialist

Job Description

Essential Duties and Responsibilities

• Ensure all the computerized systems meeting the 21 CFR Part 11, EU ANNEX 11and GAMP5 guidelines requirements.
• Perform, review & approve computerized system validation life cycle deliverables.
• Responsible for implementation and compliance of data integrity at site as DICO (Data Integrity Compliance officer).
• Implement regimen of Data integrity checks on shopfloor and updating of Data Integrity Risk Assessment (DIRA).
• Responsible for handling and compliance of SOPs related to Data Integrity & IT systems.
• Review / conduct of investigations related to Data integrity, Computerized Systems, and engineering department as applicable.
• Coordination for data integrity and IT-systems projects with stakeholders at site and corporate.
• Handling & Participation in internal & Data Integrity audits.
• Involve in selection of Data Integrity (DI) champions & impart necessary trainings to the DI champions.
• Review of Change controls, Deviations, CAPA and other QMS tools.
• Review of Periodic review reports.
• Participated in supplier assessment for Computerized Systems, instruments & equipment's etc.
• Review approve the schedules of data back-up & restoration, time synchronization etc.
• Audit trail reports review of computerized systems.
• Review and ensure the compliance of user management activities of Computerized Systems.
• Preparation / review of the quality risk assessments i.e. part 11 compliance, data integrity etc.
• Review the Qualification documents of the manufacturing equipment's, facility, utilities and associated ancillary systems.
• CAPA effectiveness verification.
• GMP compliance verification for the manufacturing equipment area, utilities and testing instruments.
• Review of software application qualifications.
• Comply with SHE Guidelines, SHE Rules and Regulations. Comply with usage of PPE wherever applicable.
• Observe noncompliant acts and conditions and take corrective & preventive actions immediately, as necessary.
• Report any incident/accident/near miss/illness to the superiors.
• Follow company's quality procedures, standards, and specifications.
• And any other job as may be assigned to you from time to time by HOD.
• Also responsible for the work of the senior, in absence of senior.

Key Competencies (knowledge, skills and abilities every person must possess to be successful)

• Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers.
• Excellent verbal and written communication skills.
• Creative and able to present various solutions.
• Energetic, enthusiastic and motivational disposition.
• Maintain confidentiality.
• Coaching skills.

Education / Experience

• Bachelor’s degree in relevant scientific quality assurance / technical field.
• 5+ years of experience.
• Strong understanding of pharmaceutical cGMP, industry standards, and regulations.
• Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority levels.
• Expert level user for Quality computer systems, Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems.
• Thorough understanding of computer system validation and GAMP requirements.
• The ability to analyze data/trends to make sound regulatory interpretation while preparing metrics and reports.
• The ability to drive projects in relation to implementation of new workflows and updates to new systems.